The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.

NCT06001502 | Recruiting DMC

• 1 other identifier: NL79616.018.21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure. Participants in the intervention group will receive a 20 minute session with the head mounted VR device on post-operative days 1,2 and 3. Participants in the control group will be treated with conventional post-operative care.

Conditions

Post Operative Pain; Post Operative Anxiety; Heart Surgery; Coronary Artery Bypass Grafting; Virtual Reality

Outcome Measures

Primary Outcomes (3)

• Numeric Rating Scale (NRS)

  The NRS score is a numeric scale in which individuals rate pain from 0 (no pain) tot 10 (worst pain). This is a subjective score which is assessed verbally and used frequently in standard clinical care in multiple medical specialties.

  Post-operative days 1,2 and 3 directly after the VR intervention

• State- Trait Anxiety Inventory 6 questionnaire

  The STAI-6 questionnaire is a validated psychological inventory designed to measure worry, tension and anxiety in an individual. It is a shortend version of the STAI score

  Post-operative days 1,2 and 3 directly after the VR intervention

• Quality of Recovery-15

  The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery.

  Post-operative days 1,2 and 3 directly after the VR intervention

Study Arms (2)

Virtual Reality group

EXPERIMENTAL

Virtual Reality distraction therapy on post-operative days 1,2 and 3.

Device: Virtual Reality distraction therapy

Control Group

NO INTERVENTION

Conventional post-operative pain and anxiety management

Interventions

Virtual Reality distraction therapy DEVICE

The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings

Also known as: Healthy Mind VR device

Virtual Reality group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years or older with written informed consent
• Patients undergoing surgical CABG

You may not qualify if:

• Major comorbidities besides coronary artery disease
• Complicated surgical procedure
• Hearing and/or visual impairments
• Psychiatric impairments
• Complaints of vomiting and nausea
• History of epilepsy
• Claustrophobia
• Facial wounds and skin defects at site of application
• Patients placed in clinical isolation
• Readmission to the intensive care unit

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jolanda Kluin, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sulayman El Mathari, MD

CONTACT

+31205668188; s.elmathari@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor dr. J. Kluin, MD, PhD

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: January 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication
• Access Criteria: Upon request available.

Locations

NL (1)